CARESS in Acute Myocardial Infarction
Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction
2 other identifiers
interventional
600
3 countries
85
Brief Summary
The aim of this study conducted in patients with high risk ST-segment elevation AMI admitted to hospitals with no PTCA facilities is to compare the effects on clinical outcome and cost-effectiveness of two reperfusion strategies:
- Fibrinolytic therapy with Abciximab and half-dose Reteplase, with rescue PTCA in case of lack of reperfusion
- Elective referral for "facilitated" PTCA after early administration of Abciximab and half dose of Reteplase
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2003
Typical duration for phase_3
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedJuly 3, 2007
September 1, 2005
September 13, 2005
July 2, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare 30 days incidence of the composite end-point of: mortality, reinfarction and refractory ischemia in the two arms of the study.
30 Day
Secondary Outcomes (3)
Compare 1 year composite end-point of: mortality, reinfarction, refractory ischemia, hospital readmission because of heart failure in the two arms;
1 Year
Compare the resource use at 30 days and 1 year, including days in CCU, MICU or general ward, cost of catheterization and PTCA, drugs, ambulance service during index hospitalization and subsequent hospital admissions for reAMI
30 Day and 1 Year
Compare the incidence of in-hospital stroke and bleeding complications in the two arms.
30 Day
Interventions
Eligibility Criteria
You may qualify if:
- \- ECG with ST-elevation (≥ 1mm in at least 2 ECG limb leads or ≥ 2 mm in 2 contiguous precordial leads) AMI within \<12 hours from symptoms onset fulfilling 1 or more of the following criteria of "high risk":
- Summation of ST-segment elevation or depression ≥ 15 mm in all 12 electrocardiographic leads or new onset complete left bundle branch block;
- Previous myocardial infarction (Q- and non Q-wave);
- Killip Class 2 or 3;
- LV ejection fraction at transthoracic ultrasound \< 40%.
You may not qualify if:
- Inability to provide informed consent;
- Age \> 75 years
- CABG or PCI procedure in past history involving the infarct-related artery;
- Participation in another study with any investigational drug or device within the previous 30 days;
- Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer);
- Cardiogenic shock (hypotension with Systolic Blood Pressure (SBP) \< 90 mmHg and tachycardia \> 100 beats / min, not due to hypovolemia and requiring inotropic support or balloon counterpulsation);
- Need for concomitant major surgery (e.g. valve surgery or resection of aortic or left ventricular aneurysm, carotid endarterectomy, abdominal aortic aneurysm surgery, congenital heart disease etc);
- Severe hepatic disease;
- Patients with acute or chronic renal impairment (serum creatinine \> 2.0 mg % or 200 mg/l or creatinine clearance \< 30 ml/min);
- Transmural MI in different location within the previous week;
- Previous administration of thrombolytics within 7 days;
- Intolerance or contraindications to ASA or Clopidogrel;
- Known leucopenia, defined as a leukocyte count of \< 3.500 White Blood Cells (WBC)/ml
- Known neutropenia, defined as \< 1000 neutrophils / ml;
- Known thrombocytopenia (\< 100.000 platelets / ml );
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Società Italiana di Cardiologia Invasivalead
- Royal Brompton & Harefield NHS Foundation Trustcollaborator
- Eli Lilly and Companycollaborator
- Biotronik SE & Co. KGcollaborator
Study Sites (85)
Cardiologie Hop. Duffaut
Avignon, 84902, France
SAMU - Hop. Duffaut
Avignon, 84902, France
Cardiologie - Hop. Louis Pradel
Bron, 69500, France
Cardiologie - CH
Caen, 14033, France
Urgences - CH
Carpentras, 84200, France
Cardiologie - CH
Cherbourg, 50100, France
SAMU - Hop. Beaujon
Clichy, 92110, France
Service de Cardiologie - Hopital St. Joseph
Colmar, 68024, France
Cardiologie - CHU
Grenoble, 38043, France
Samu - Chu
Grenoble, 38043, France
SAMU 69 - Hop. E. Herriot
Lyon, 69437, France
Cardiologie - Hop. Bichat
Paris, 75018, France
Centre Cardiologique du Nord
Saint-Denis, 93200, France
SMUR Delafontaine
Saint-Denis, 93200, France
SAMU - Reanimation - CH
Sélestat, 67604, France
Ospedale San Donato
Arezzo, 50100, Italy
Presidio Ospedaliero del Casentino
Bibbiena, 52011, Italy
Spedali Civili
Brescia, 25123, Italy
Az. Ospedaliera di Circolo
Busto Arsizio, 21052, Italy
P.O. di Camposampiero
Camposampiero, 35012, Italy
Ospedale Ramazzini
Carpi, 41012, Italy
Ospedale Bufalini
Cesena, 47023, Italy
P.O. Cittadella
Cittadella, 35013, Italy
P.O. di Codogno
Codogno, 26845, Italy
Ospedale di Conegliano
Conegliano, 31015, Italy
Ospedale S. Giuseppe da Copertino
Copertino, 73043, Italy
Ospedale S. Sebastiano
Correggio, 42015, Italy
P.O. di Cortona
Cortona, 52044, Italy
Ospedale Santa Croce e Carle
Cuneo, 12100, Italy
Ospedale di Desio
Desio, 20033, Italy
Ospedale Santa Maria del Prato
Feltre, 32032, Italy
Ospedale S. Sebastiano Martire
Frascati, 00044, Italy
Ospedale Santa Caterina Novella
Galatina, 73013, Italy
Ospedale La Memoria
Gavardo, 25085, Italy
Ospedale San Giuliano
Giugliano in Campania, 80014, Italy
Ospedale di Guastalla
Guastalla, 42016, Italy
Az. Osp.Vito Fazzi
Lecce, 73100, Italy
Ospedale Civile di Legnano
Legnano, 20025, Italy
Az. Ospedaliera Desenzano sul Garda
Manerbio, 25025, Italy
Fondazione Centro San Raffaele del Monte Tabor IRCCS
Milan, 20132, Italy
Hesperia Hospital
Modena, 41100, Italy
Nuovo Ospedale S. Agostino Estense - Baggiovara
Modena, 41100, Italy
Ospedale Civile
Mondovì, 12084, Italy
P.O. di Montebelluna
Montebelluna, 31044, Italy
Ospedale Franchini
Montecchio, 42027, Italy
Azienda Universitaria Federico II
Napoli, 80131, Italy
Ospedale Santa Maria delle Grazie
Pozzuoli, 80078, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, 42100, Italy
Ospedale Civile
Riccione, 47038, Italy
Ospedale degli Infermi
Rimini, 47900, Italy
Ospedale S. Eugenio
Roma, 00100, Italy
A.O. San Camillo
Roma, 00152, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
P.O. U.O. Struttura Complessa
San Giovanni Valdarno, 52027, Italy
Ospedale della Valtiberina
Sansepolcro, 52037, Italy
Ospedale Provinciale di Saronno
Saronno, 21047, Italy
Nuovo Ospedale Civile di Sassuolo
Sassuolo, 41049, Italy
Ospedale SS.Annunziata
Savigliano, 12028, Italy
Ospedale M. Scarlato
Scafati, 84018, Italy
Ospedale Magati
Scandiano, 42010, Italy
Az. Ospedaliera Galmarini
Tradate, 21049, Italy
Ospedale Cà Foncello
Treviso, 31100, Italy
Specjalista Chorob Wewnetryznich
Będzin, 42500, Poland
Oddzial Chorob Wewnetrznych
Brzesku, 32800, Poland
Szpital Powiatowy w Chrzanowie
Chrzanów, 32500, Poland
Oddzialu Kardiologicznego
Dąbrowa Górnicza, 41300, Poland
Oddzialu Chorob Wewnetrznych
Dąbrowa Tarnowska, 32200, Poland
II Oddzial Kardiologiczno - Wewnetrezny Szpital Miejski w Jawozznie
Jaworzno, 43600, Poland
Oddzial Wewneztrnj Okregowy Szpital Kolciowy
Katowice, 40760, Poland
First Dept. Cardiology - Gornoslaskiego Centrum Medycznego
Katowice, 41635, Poland
Zaklad Hemodynamiki i Angiokardiografii Pracownia 1
Krakow, 31202, Poland
Zaklad Hemodynamiki i Angiokardiografii - Pracownia 2
Krakow, 31501, Poland
Oddzial Wewnetrzny - Szpital Mijski w Krynicy
Krynica, 33380, Poland
Oddzial Wewnetrzny - Szpital Powiatowy w Limanowej
Limanowa, 34600, Poland
Oddzial Internistyczno- kardiologiczny
Nowy Sącz, 33300, Poland
Oddzial Kardiologiczny
Nowy Targ, 34400, Poland
Szpital Powiatowy im. Sw. Maksimiliana w Oswiecimiu
Oświęcim, 32600, Poland
Oddzial Intensywnej Opieki Kardiologicznej i Kardiologii Olgonej
Sosnowiec, 41200, Poland
Zaklad Opieki Zdrowotnej
Sucha Beskidzka, 34-200, Poland
Oddzial Wewnetrzny Szpital w Szczyrzu
Szczyrzyc, 34623, Poland
Oddzial Kardiologii Inwazijnej - Szpital im. E. Szczeklika
Tarnów, 33100, Poland
Oddzialu Kardiologii z OIOK
Tarnów, 33100, Poland
Oddzial Kardiologii - Szpital Miejski w Tychach
Tychy, 43100, Poland
Szpital Powiatowy im. Jana Pawla II w Wadowicach
Wadowice, 34100, Poland
Oddzial Kardiologii - Szpital Powiatowy w Zakopane
Zakopane, 34500, Poland
Related Publications (2)
Di Mario C, Bolognese L, Maillard L, Dudek D, Gambarati G, Manari A, Guiducci V, Patrizi G, Rusconi LC, Piovaccari G, Hibon AR, Belpomme V, Indolfi C, Olivari Z, Steffenino G, Zmudka K, Airoldi F, Panzarasa R, Flather M, Steg PG. Combined Abciximab REteplase Stent Study in acute myocardial infarction (CARESS in AMI). Am Heart J. 2004 Sep;148(3):378-85. doi: 10.1016/j.ahj.2004.03.038.
PMID: 15389222BACKGROUNDDi Mario C, Dudek D, Piscione F, Mielecki W, Savonitto S, Murena E, Dimopoulos K, Manari A, Gaspardone A, Ochala A, Zmudka K, Bolognese L, Steg PG, Flather M; CARESS-in-AMI (Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction) Investigators. Immediate angioplasty versus standard therapy with rescue angioplasty after thrombolysis in the Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS-in-AMI): an open, prospective, randomised, multicentre trial. Lancet. 2008 Feb 16;371(9612):559-68. doi: 10.1016/S0140-6736(08)60268-8.
PMID: 18280326DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leonardo Bolognese, MD, Ph D
Ospedale San Donato - Arezzo Italy
- PRINCIPAL INVESTIGATOR
Gabriel P. Steg, MD. Ph D
Hopital Bichat - Paris France
- PRINCIPAL INVESTIGATOR
Darius Dudek, MD, Ph D
Jagellonian University Krakow Poland
- STUDY CHAIR
Carlo Di Mario, MD
Royal Brompton and Harefield Hospital - London UK
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
May 1, 2003
Study Completion
March 1, 2007
Last Updated
July 3, 2007
Record last verified: 2005-09